N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110

N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 is an FDA 510(k)-cleared medical device (K043383) manufactured by Physion, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2005. Regulation: 8.